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Policy
Mandatory notification for correctional facilities
by
Kim, Jung-Ju
Aug 02, 2022 06:02am
A bill that stipulates that the MFDS should also notify the MFDS of narcotics prescriptions conducted at correctional facilities and military units will be promoted. Representative Choi Yeon-sook of the People's Power represented the partial revision bill of the Drug Management Act. With the increase in the handling of medical narcotics, the MFDS is reporting related matters from drug handlers through the integrated drug management system to manage the handling of narcotics. It is pointed out that the integrated drug management system cannot confirm the prescription of drugs in the correctional facility, and that it is difficult to confirm the prescription of drugs in the Ministry of National Defense under the current law. The main purpose of this amendment is to prevent misuse of narcotics and to resolve blind spots by stipulating to the MFDS about the prescription of narcotics and prescription of narcotics in the Ministry of National Defense. This bill is based on the premise of the resolution of the "Partial Amendment of the Act on the Execution of Sentences and the Treatment of Detainees" proposed by Choi. Therefore, if this bill is not resolved or revised, it must be adjusted accordingly. This initiative will be joined by Rep. Choi, Kang Min-guk, Kwon Eun-hee, Seo Byung-soo, and Chung Chang-min, Kim Min-seok of the Democratic Party of Korea, Rep. Ryu Ho-jung, and Rep. Lee Eun-joo of the Justice Party , Independent Party Yang Jung-sook and Yang Hyang-ja.
Policy
Daewoong sells the original Ebixa
by
Lee, Tak-Sun
Aug 01, 2022 09:16pm
Daewoong Pharmaceutical, which once sought to develop a high-dose dementia treatment Ebixa, sells original drug in Korea instead of giving it up. Ebixa 20mg, a higher dose than the existing product, is expected to greatly improve the convenience of taking it because patients only need to eat one dose a day. According to the industry on the 29th, Daewoong Pharmaceutical, which has signed a joint sales contract with the original company Lundbeck since 2019, will also carry out a copromotion of Ebixa 20mg, which will be listed on August 1. Ebixa 20mg will be listed at 1, 606 won starting August 1. It is twice the price of the existing Ebixa at 803 won. However, it improves the ease of use. Existing Ebixa requires two tablets a day, but Ebixa 20mg, which has increased the dose, requires only one tablet a day. Daewoong Pharmaceutical is conducting domestic sales and marketing of Ebixa in all sectors, including hospitals, hospitals, and clinics, while conducting a copromotion between Lundbeck and Ebixa in 2019. Ebixa is an NMDA receptor antagonist and has a mechanism to alleviate symptoms by inhibiting excessive NMDA receptor stimulation in the brain of Alzheimer's patients. It is the second most commonly used drug after Eisai's Aricept. Based on UBIST last year, Aricept was 86.1 billion won and Ebixa was 16.9 billion won. Lundbeck is counting on this Ebixa 20mg to close the gap with Aricept. It is calculated that as the convenience of taking has improved, the number of Rxs will increase. Daewoong Pharmaceutical also expects Ebixa 20mg to help improve the market share of dementia drugs in Korea. In particular, Daewoong Pharmaceutical attempted to develop 20mg of Memantine directly before Ebixa 20mg was approved in Korea. In April 2020, the MFDS approved a phase 1 clinical trial under the name DWJ1458, which is known as the development of Memantine 20mg.Daewoong Pharmaceutical stopped clinical research after two months of clinical approval. There were various interpretations of this at the time, but the original Ebixa 20mg copromotion solved the curiosity neatly. Aricept had the domestic license right. After that, the license was transferred to Handok, and Daewoong is currently registered as a consignment producer. Daewoong entered the dementia treatment market directly from Ebixa. Ebixa's propaganda is also needed to make up for the reduction in benefit through re-evaluation of its affiliate, Daewoong Bio's brain function improvement drug Gliatamin.
Policy
MFDS Minister promises COVID-19 vaccineˑTx support
by
Lee, Hye-Kyung
Aug 01, 2022 05:58am
The Minister of Food and Drug Safety Yoo-Kyung Oh met with COVID-19 vaccine and treatment developers and relevant associations and promised support in the future. On the 29th, the MFDS held an MFDS-Industry roundtable meeting for the COVID-19 vaccine-treatment development support. The meeting was held to discuss the difficulties experienced by developers in conducting clinical trials and MFDS’s measures of support in situations where the development of a homegrown vaccine or treatment becomes imperative due to an epidemic. At the event, the MFDS introduced its measures for support in commercializing such products, listened to the difficulties that the industry experienced in the process of developing COVID-19 vaccines, and discussed measures of MFDS support for the development of vaccines and treatments. Minister Oh said, “Korea is an established leader in the pharma-bio sector that owns both a vaccine and treatment for COVID-19. The MFDS will continue to innovate regulations in the field to support the rapid commercialization of homegrown COVID-19 vaccines and treatments." Also, Oh mentioned that it has been linking development-non-clinical trials, clinical trials-approval & review processes while providing professional support on clinical trial design through the commercialization strategy support task force that had been established in April. Minister Oh said, “We plan to seek more efficient operation of the approval and review process for COVID-19 vaccines and treatments through rapid review, rolling review, etc. while thoroughly reviewing their efficacy and safety through close review and expert advice." Companies and related associations that participated in the meeting expressed their gratitude to the MFDS for enabling easier export of products upon domestic approval, which has advanced its regulations through safety-based regulatory innovation and commercialization support efforts and asked for the ministry’s continued support for rapid vaccine development against variants and clinical trial subject recruitment. The companies said, “It is imperative that the MFDS recruits more review personnel to enable rapid development of the second, third homegrown vaccines and treatments. We ask the MFDS to increase their review personnel and strengthen its expertise.” The MFDS expects the meeting to help identify various difficulties experienced in development and come up with support measures. The ministry added it will do its best to support the rapid development of domestic vaccines and treatments by operating programs specialized for COVID-19 and commercialization strategy support teams - such as ‘Our Vaccine Project’ and the ‘Development-focused support council’ - for the prompt development of homegrown vaccines and treatments.
Policy
MFDS announces a series of tasks for innovation
by
Lee, Hye-Kyung
Jul 29, 2022 05:51am
“If the 3 strategies set for the direction of the food and drug administration are the three mountains to conquest for the Ministry of Food and Drug Safety, the 100 National Tasks Roadmap that will be announced soon is like the 100 trees that we will be planting on the 3 mountains." Yu-Kyoung Oh, Minister of Food and Drug Safety, announced so at the ‘Briefing on the Standards for Globally Leading Innovative Food and Drug Administrative Measures ’ that was held at 1:30 p.m. on the 28th. After holding a public debate on regulatory innovation for the pharmaceutical sector on the 21st and the food sector on the 25th, the MFDS finally announced the measures for food and drug administrative innovation at the briefing. The 100 regulatory innovation tasks that will form the detailed tasks under the innovative measures, will be established and announced in line with the 100th day of President Suk-Yeol Yoon’s inauguration. The MFDS’ administrative measures for innovation will be to innovate its regulatory capabilities to a global level, support the global entry of new technologies with guaranteed safety, and enable the public to quickly enjoy the benefits of new technologies. Minister Oh said, “Global entry of drugs in the past had been difficult because the private companies had to seek their own paths of entry after the MFDS completes the approval process. As it is a regulated industry, each country has its own and diverse regulatory barriers." Therefore, the MFDS plans to analyze the global food and drug regulatory policies and operate a strategy task force to allow the industry to enter the global market after penetrating the regulatory barriers set for each country. Yoon-Joo Park, Director-General of the MFDS’s Drug Evaluation Department, said, “New product development has been increasing in the biohealth industry with scientific innovations like AIs as well as environmental changes. We will raise our regulatory capabilities so that passing the regulatory scientific standards set by the MFDS would mean that it could pass those set by global regulatory institutions.” Also, the operation of the three-tier system for regulatory relief that includes outside experts had been further explained at the briefing. (From the left) Yu-Kyoung Oh, Minister of Food and Drug Safety; Sang-Bae Han, Director General for Planning & Coordination; Oh-Sang Kwon, Director-General of the Food Safety Policy Bureau; Yoon-Joo Park, Director General of the Drug Evaluation Department; Sang-Bong Kim, Director General of Biopharmaceuticals and Herbal Medicine Bureau; Nam-Hee Lee, Director-General of the Medical Device Safety Bureau; Suk-Yeon Kang, Director-General of the Pharmaceutical Safety Bureau Sang-Bae Han, Director General for Planning & Coordination, said, “When a company requests regulation relief, the relevant departments first respond and make evaluations at the first tier. If the request is not accepted at in first tier, the company’s request goes on to the second tier and is applied the regulatory verification responsibility system.” The second tier mainly consists of civilian experts who will be determining whether the deregulation request should be accepted. Han said, “If the request is again not accepted at the second tier, we apply the last and final third tier, where the Minister of Food and Drug Safety directly checks the facts and seek for alternatives.” Regarding the ‘WHO Listed Authorities (WLA)’ that is being promoted, Minister Oh said, “The WHO has high regards for Korea’s regulatory capabilities and is reviewing Korea as the first candidate for WLA listing. We will be listed on the WLA at the end of this year at the earliest, and by next year at the latest. Suk-Yeon Kang, Director-General of the Pharmaceutical Safety Bureau, said, “We have started receiving the WLA review from March this year, and 56 countries are currently on the tentative list. Korea is also on the tentative list, but we are being reviewed as the first candidate as the WHO recommended that we receive evaluations as the most qualified country for listing.”
Policy
500 billion won fund by the end of this year
by
Lee, Jeong-Hwan
Jul 28, 2022 05:54am
Public-private partnerships to develop blockbuster vaccines and treatments. The government will focus on supporting vaccines and treatments for infectious diseases under development by domestic bio-health companies. It plans to fully support vaccine candidate materials for diseases such as COVID-19 and core technologies for responding to infectious diseases, and strengthen licensing, location, and foundation support, tax deduction and financial support to revitalize private investment in biohealth. It will also expand public-private investments such as K-bio and vaccine funds, and will create a joint public-private fund worth 500 billion won within this year and pay a total of 2.2 trillion won in R&D expenses for new drug pipelines. The MOHW discussed the "BioHealth Industry Innovation Plan" at the 4th Emergency Economic People's Assembly presided over by President Yoon Seok-yeol on the morning of the 27th. The MOHW diagnosed that Korea's investment in vaccine and treatment development support is limited compared to other developed countries. Compared to AstraZeneca's development of COVID-19 vaccines and treatments with 2 trillion won, 1.9 trillion won for Novavax, and 550 billion won for Janssen, Korea spent only 257.5 billion won for vaccines and 155.2 billion won for treatments. The MOHW decided to continue to support the development of COVID-19 vaccines and treatments from 17 companies under clinical trials in six domestic companies. It helps Korea's No. 1 vaccine to enter the global market by passing the pre-qualification examination by the WHO and confirming the efficacy of additional vaccinations. After securing core technologies by researching and developing vaccine candidate materials for COVID-19 as well as candidates for infectious diseases such as MERS and Zika virus, it supports rapid development of vaccines in case of crisis. In order to revitalize private investment worth 13 trillion won by 2026, including Samsung Biologics, Lotte Biologics, SK Bioscience, and EuBiologics, it will also provide support at the level of ministries. It will closely support licensing, location, and foundation creation, and quickly strengthen tax deductions, financial and policy funding support for each major related institution, and expansion of support limits. In a recently announced tax reform plan to promote investment in vaccines, the deduction rate for investment in national strategic technology facilities of large companies was raised from 6% to 8%. In order to develop innovative new drugs and secure vaccine autonomy, it will create a private joint "K-Bio and Vaccine Fund" worth 500 billion won that invests in pharmaceutical and bio companies within this year, and expand it to 1 trillion won in the future. It has also decided to provide 2.2 trillion won in research and development expenses, including 1.5 trillion won in state funds, to new drug pipelines that have entered the second phase of clinical trials in discovering effective substances. Regulatory innovation will also be carried out. Innovative medical devices such as AI and digital will be improved so that they can be used as non-reimbursement or Medical Benefits after licensing. In the case of innovative medical devices, the evaluation period required for them to be put into the medical field after minimum administrative measures after licensing will be drastically reduced from 390 days to 80 days. It will fully redesign regulatory systems suitable for high-tech product characteristics such as digital and high-tech bio to closely support entry into the global market, and establish a biohealth-specific regulatory sandbox that reflects the specificity of innovative technologies and services. Lee Ki-il, the second vice minister of the MOHW, said, "We will present a roadmap for bio-health regulatory innovation and actively resolve difficulties through continuous communication with the industry."
Policy
Outpatient tx 14.7 times a year per person in Korea
by
Kim, Jung-Ju
Jul 28, 2022 05:54am
In 2020, the number of outpatient treatments per capita in Korea was 14.7 times a year, the highest among OECD countries. This is 2.5 times the average 5.9 times of member states. As a result of evaluating drug sales per capita with Purchasing Power Parity (PPP) reflecting the price level of each country, $ 760.9 PPP was 1.4 times higher than the OECD average of $547.2 PPP. The MOHW analyzed and announced the level and status of Korea and each country by major indicators of "OECD Health Statistics 2022" announced by the OECD on the 4th. Among them, we looked at health care use and health care resources. ◆ Outpatient treatment, average number of days of hospitalization, examination, and current medical expenses = In 2020, the number of outpatient treatments per capita in Korea was 14.7 times a year, the highest among OECD countries, 2.5 times higher than the average of member countries (5.9). Japan (12.4) has the second highest number of outpatient treatments per person after Korea, while Costa Rica (1.9), Mexico (2.1), Chile and Sweden (2.2), Colombia (2.6) and Greece (2.7) have less than three. In 2020, the average number of hospitalization days per inpatients in Korea was 19.1, the second longest among OECD countries after Japan (28.3 days). The OECD average is 8.3 days. The average number of hospitalization days per inpatients for acute treatment was 7.8 days, longer than the OECD average (6.6 days). Over the past 10 years, the average number of hospitalization days per inpatients in Korea has been on the rise, but the number of patients treated in acute phase has been on the decline. The total number of hospitalizations increased by 1.9% annually, and acute treatment decreased by 2.5% annually. In 2020, Korea's MRI usage was 71.7 cases per 1,000 people, which was lower than the OECD average, and CT was 250.0 cases per 1,000 people, which was higher than the OECD average. Over the past 10 years, CT and MRI usage in Korea has continued to increase. CT usage increased by 8.3% annually, and MRI usage increased by 14.6% annually. Current medical expenses, which mean the total annual expenditure of the entire people spent on services and goods in the health care sector, were 8.4% of GDP in 2020, lower than the OECD average (9.7%). The per capita current medical expenses were $3,582.3, an annual average increase of 6.9% over the past 10 years, higher than that of the OECD (3.3%). The proportion of medical expenses (direct household burden) borne by households gradually decreased to 34.0% in 2010, 33.7% in 2015, and 27.8% in 2020. ◆ Number of beds and medical equipment = In 2020, the number of hospital beds was 12.7 per 1,000 people, the largest among OECD countries, and about 2.9 times the OECD average (4.3). Among them, 7.2 beds per 1,000 people were treated in acute phase, more than twice the OECD average (3.5). In 2020, Korea's number of MRIs was 34.2 per 1 million people and CT was 40.6 per 1 million people, which was higher than the OECD average (29.1 units). "OECD Health Statistics is important to use as basic data for policies to provide the quality of health care services that people can feel directly by analyzing and evaluating the level of health care in Korea in the international community," said Yang Kyung-jin, a policy statistics officer.
Policy
The revised COVID-19 in vitro diagnostic device guidelines
by
Lee, Hye-Kyung
Jul 27, 2022 05:50am
Due to the prolonged COVID-19, the in vitro diagnostic devices of the MFDS and the Korea Food and Drug Safety Evaluation Institute were very busy. Since the outbreak of COVID-19, the export performance of in vitro diagnostic medical devices has increased by 1.5 times, and the degree felt by in vitro diagnostic departments is said to be 10 times. Currently, in vitro diagnostic devices are operated on a small scale with four researchers and five examiners. However, five examiners are reviewing the workload for approval of in vitro medical devices from 800 companies. Jung Ho-sang, head of the in vitro diagnostic device division, said in a briefing to the journalists on the 26th, "Before COVID-19, there were many complaints about imported products of in vitro diagnostic devices used in hospitals." "However, after COVID-19, the development and permission management of product lines that used a lot and had a lot of complaints have decreased, and the situation has become to focus on COVID-19," he explained. He said, "The number of applications for permission from companies that have no experience in developing COVID-19-related devices has increased, resulting in a surge in complaints." "It is not easy to replenish manpower, so there are many difficulties," he said. Fortunately, applications for permission for new products have not increased despite the current COVID-19 resurgence. Foreign companies are reportedly putting in complaints for permission for cancer diagnosis and blood diagnosis devices, which have been stopped while focusing on developing COVID-19-related devices. Manager Jeong said, "Foreign companies are focusing on COVID-19 and restarting devices such as cancer diagnosis and blood diagnosis, which have rarely been developed. There are still many applications for permission for COVID-19-related devices, but foreign companies have completed the development of COVID-19 diagnostic test kits and are receiving a lot of complaints about devices that have already been developed or have now begun." There was also an explanation of the recently revised guidelines for the approval review of COVID-19 in vitro diagnostic devices. The MFDS deleted design restrictions that detected two or more genes only for COVID-19 gene test reagents, and added data on major mutation virus detection performance evaluation designated by the WHO as a prerequisite. He explained, "It is not true that the revision of the guidelines eased the criteria for approval of test reagents." Regardless of the revision of the guidelines, the COVID-19 gene test reagent must meet the same licensing criteria as before regardless of the number of detected genes, he said. "The clinical performance criteria with a sensitivity of 95% or higher and a specificity of 97% or higher are applied without change." In Korea, 46 gene test reagents have already been approved to detect two or more genes, and he added, "In accordance with the Korea Centers for Disease Control and Prevention's diagnosis guidelines, more than two genes are tested, so it does not affect the COVID-19 diagnosis system at all." However, as products targeting multiple genes are advantageous in detecting mutations in response to the new mutation virus, it is expected that the development of products targeting multiple genes will continue under the current epidemic and the Korea Centers for Disease Control and Prevention's diagnostic guidelines. Regarding the deletion of design restrictions on genetic test reagents, he said, "We decided that there was no need to limit the design of genetic test reagents anymore because many genetic test reagents were performing well at home and abroad." He said, "This is to promote the development of new products and additional product types according to changes in the COVID-19 quarantine situation."
Policy
COVID-19 improved vaccines will be promoted
by
Kim, Jung-Ju
Jul 27, 2022 05:49am
The quarantine authorities said they have already begun work to quickly introduce an improved vaccine, an upgraded version of the COVID-19 vaccine. Currently, Pfizer and Moderna have signed a contract to introduce 60 million doses within the year, and if an improved vaccine is released in the meantime, the main point is to replace it with this. The details will be announced at the end of next month. According to the Korea Centers for Disease Control and Prevention on the 25th, the government is continuing to consult with pharmaceutical companies for quick introduction and safe and effective vaccination, and plans to announce the vaccination plan at the end of August. The U.S. and Japan have decided to actively use an improved vaccine that is more effective for omicron mutations in the fourth vaccination for the entire nation this fall. The amount of mRNA vaccine (Pfizer & Moderna) introduced within this year is about 60 million times. The Korea Centers for Disease Control and Prevention said, "Pharmaceutical companies have signed a contract to introduce the quantity as an improved vaccine if an improved vaccine is developed." The Korea Centers for Disease Control and Prevention explained, "This is enough for inoculation in the second half of the year." The government also held frequent monitoring and consultations with pharmaceutical companies on vaccine development trends to quickly introduce improved vaccines, and is always consulting experts. The Korea Centers for Disease Control and Prevention said, "The direction of the vaccination policy using the improved vaccine will be announced around the end of August after comprehensively reviewing the effectiveness and safety of the vaccine, development progress, introduction time and available quantity." The Korea Centers for Disease Control and Prevention said, "However, detailed inoculation strategies such as specific inoculation targets, timing, and method can be determined based on scientific grounds such as the type of mutation that is prevalent at the time of inoculation and the effect of improved vaccines on the mutation." The Korea Centers for Disease Control and Prevention added, "We are monitoring quarantine situations, new mutation trends, improved vaccine development trends, and overseas vaccination policies so that vaccinations through improved vaccines can be effectively carried out in a timely manner."
Policy
Paxlovid·Lagevio, the effect of inhibiting viral proliferat
by
Kim, Jung-Ju
Jul 25, 2022 05:57am
The National Institute of Influential Diseases (Director Jang Hee-chang) under the Korea National Institute of Health (Director Kwon Joon-wook) announced the results of the efficacy evaluation of treatments such as COVID-19 PO treatments, that is, Paxlovid and Lagevrio. Compared to the existing delta mutant virus, these drugs have maintained their effectiveness in suppressing virus proliferation, so they are not affected by omicron submutation. It was decided to prepare treatment guidelines through research on chronic aftereffects in the future. First, the National Institute of Influential Diseases evaluated the efficacy of three domestic COVID-19 antiviral drugs (Paxlovid, Lagevrio, Remdesivir) through cell-level analysis, and confirmed that Paxlovid and Lagevrio maintained their anti-virus proliferation inhibitory efficacy compared to the existing virus delta strain. Remdesivir, which is used as an injection, has been confirmed to still maintain antiviral efficacy for four types of omicron subdisplacement. The National Institute of Infectious Diseases announced that it will continue to monitor domestic and foreign treatment development trends and evaluate the efficacy of treatments in use in Korea in the event of a new mutation virus. The Korea National Institute of Health is promoting a large-scale systematic investigation and research project to prepare measures to manage chronic COVID-19 syndrome (aftermath) in Korea due to COVID-19. This project is a long-term observation and in-depth investigation study on large-scale aftereffects cohorts, including children and adolescents, and a study on identifying patterns, causative mechanisms, and preparation of treatment guidelines based on clinical cohorts. Currently, the announcement of research projects to select the main research institutes has been completed and related procedures such as selection evaluation are underway, and research will be launched by signing an agreement at the end of August. The Korea National Institute of Health said it will make efforts to quickly secure and provide information on systematic scientific evidence for treatment and management through this chronic COVID-19 syndrome cohort study.
Policy
Donepezil patch is cheaper than 99 existing formulations
by
Lee, Tak-Sun
Jul 22, 2022 05:53am
Donepezil, a dementia treatment that has attracted attention for its convenience of administration, has been listed at a lower price than existing drugs, indicating that it has price competitiveness. 87.5mg patch, which replaces the existing 5mg tablet, costs 8,310 won per week, which is about 6,000 won cheaper than the highest price of the tablet. It's lower than the latest production. The Health Insurance Policy Review Committee of the Ministry of Health and Welfare held a meeting on the 20th and deliberated and voted on the upper limit of ICure Donhesive Patch and Celltrion Pharmaceutical Donerion. The two drugs were jointly developed by the two companies. Icure leads the commercialization clinical trial and is licensed jointly with Celltrion Pharmaceutical. The production is handled by the ICure. It is the first product to make Donepezil, which dominates the Alzheimer's dementia symptom treatment market by 80%, in the form of a patch. In particular, unlike oral drugs that must be taken every day, it is expected that the compliance of dementia patients who forget to take medicine will be greatly improved as they only need to be attached twice a week. The Korean Dementia Association believes that the drug is clinically useful because it has improved safety and convenience of taking medicine compared to oral drugs. Looking at the upper limit registered this time, it was found that it has such convenience and economy. The upper limit of 87.5mg, which is attached twice a week, was set at 4,155 won and 175mg at 6,076 won. This is less than 90% of the weighted average of generics. 87.5 mg replaces the existing 5 mg tablet taken once a day. The weekly price of 5mg tablets is distributed in various ways, with 125 products ranging from the lowest price of 3,500 won to the highest price of 14,420 won. The original Aricept 5mg has an upper limit of 1,902 won per day, and the price per week is 13,314 won. The 87.5mg patch is about 5,000 won cheaper. Initially, ICure and Celltrion Pharmaceutical also predicted that they would sell it cheaper than the original, but it came out cheaper than expected. It is much cheaper than powder type, which was first listed last month. Hyundai Pharmaceutical's Hypezil. The price of 5mg powder is 11,900 won, which is 3,590 won more expensive than 87.5mg patch. From a company's point of view, if the sales volume is the same, the price must be high to make more profits. However, since Donepezil is already a market where more than 100 pharmaceutical companies compete due to the expiration of patents and the recognition of original drugs is high, some analysts say that it will be difficult to settle in the market if the price is high as generics. Celltrion Pharmaceutical is on the verge of withdrawing its benefit as Godex, which has recently reached 70 billion won in sales, concluded that it is not suitable for the evaluation. Celltrion Pharmaceutical is also selling products that are acquired by its parent company Biosimilar and Takeda. But there is a lack of blockbuster brands other than Godex. Attention is being paid to whether Donerion Patch, which will be released this time, can be a representative item of Celltrion Pharmaceutical that connects Godex.
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